Impact of the Therapeutic Education on the Quality of Life of the Child Suffering of Food Allergy IgE-mediated (EducAA)

April 15, 2019 updated by: Assistance Publique - Hôpitaux de Paris

Impact of the Therapeutic Education on the Quality of Life of the Child From 8 to 12 Years Old (and His Family) Suffering of Food Allergy IgE-mediated.

The purpose of the study is to determine whether therapeutic education can improve the quality of life of the child from 8 to 12 years old suffering of food allergy.

This study also show us if therapeutic education has an effect on the quality of life of child's family.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Food allergy affects 5 - 6% of children. The major risk is anaphylaxis by ingestion of the forbidden allergen. The child and his family have to learn to deal with this risk. Therapeutic education can help the children to take care of their allergy.

Food allergy limits the child socialisation, leads to anxiety/fear, and impairs health-related quality of life. In the day of today, there is no cure treatment. Also, improve the quality of life is one of the goals of the food allergy management.

The impact of therapeutic education on quality of life has never been studied. We intend to study the impact of therapeutic education on the quality of life of children from 8 to 12 years old with IgE mediated food allergy.

Our hypothesis is the quality of life can be improved by therapeutic education.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Necker Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • IgE mediated food allergy
  • Child from 8 to 12 years old (included)
  • Family who can have an internet access
  • Children which parents have received study's information
  • Child who can have a medical examination before inclusion (art. L.1121-11 du CSP).
  • Patients who have a medical insurance.

Exclusion Criteria:

  • Non IgE mediated food allergy
  • Child with chronic disease, except asthma and atopic dermatitis
  • Patients who already had a therapeutic education for food allergy
  • Patient already included in another study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapeutic education group

At first, all patients will be invited to participate in a study of troop having for objective to estimate their quality of life. Then, the doctors offer patients randomized to therapeutic education to have a therapeutic education before the 4th month.

The sessions will be led by a multidisciplinary equip. Each child and his family will have a therapeutic session (2 times 2 hours).
Behavioral: Therapeutic education group
No Intervention: Control group
At first, all patients will be invited to participate in a study of troop having for objective to estimate their quality of life. Then, the patients randomized in this group will have the habitual medical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Child FAQLQ global score
Time Frame: month 12
month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Child FAQLQ global score
Time Frame: month 4
month 4
Child FAQLQ global score
Time Frame: month 6
month 6
All cause which can be influence the quality of life, especially occurrence of anaphylactic reactions
Time Frame: month 12
month 12
Parent FAQLQ global score
Time Frame: month 4
month 4
Parent FAQLQ global score
Time Frame: month 6
month 6
Parent FAQLQ global score
Time Frame: month 12
month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

French Society of Allergology
Stallergenes laboratories
Picot-Lactalis laboratory
ALK Industries

Investigators

  • Principal Investigator: Chantal KARILA, MD, PhD, Necker Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2014

Primary Completion (Actual)

October 7, 2016

Study Completion (Actual)

October 7, 2016

Study Registration Dates

First Submitted

April 3, 2014

First Submitted That Met QC Criteria

April 7, 2014

First Posted (Estimate)

April 8, 2014

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A01104-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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